Effect of varying levels of disease management on smoking cessation: A randomized trial

Background: Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice. Objective: To compare cessation rates among smokers who receive pharmacotherapy alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback. Design: Randomized clinical trial from June 2004 to December 2007. Setting: 50 rural primary care practices. Participants: 750 persons who smoke more than 10 cigarettes per day. Intervention: Pharmacotherapy alone (n = 250), pharmacotherapy supplemented with up to 2 counseling calls (moderate-intensity disease management) (n = 249), or pharmacotherapy supplemented with up to 6 counseling calls (high-intensity disease management) (n = 251). Interventions were offered every 6 months for 2 years. All participants were offered free pharmacotherapy. Moderate-intensity and high-intensity disease management recipients had postcounseling progress reports faxed to their physicians. Measurements: Self-reported, point-prevalence smoking abstinence at 24 months (primary outcome) and overall (0 to 24 months) analyses of smoking abstinence, utilization of pharmaco- therapy, and discussions about smoking with physicians (secondary outcomes). Research assistants who were blinded to treatment assignment conducted outcome assessments. Results: Pharmacotherapy utilization was similar across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) participants requesting pharmaco-therapy during the first, second, third, and fourth 6-month treatment cycles, respectively. Of participants who saw a physician during any given treatment cycle, 37.5% to 59.5% reported that they had discussed smoking cessation with their physician; this did not differ across the treatment groups. Abstinence rates increased throughout the study, and overall (0 to 24 months) analyses demonstrated higher abstinence among the high-intensity disease management group than the moderate-intensity disease management group (odds ratio [OR], 1.43 [95% CI, 1.00 to 2.03]) and among the combined disease management groups than the pharmaco-therapy-alone group (OR, 1.47 [CI, 1.08 to 2.00]). Self-reported abstinence at 24 months was 68 of 244 (27.9%) and 56 of 238 (23.5%) participants in the high- and moderate-intensity disease management groups, respectively (OR, 1.33 [CI, 0.88 to 2.02]), and 56 of 244 (23.0%) participants in the pharmacotherapy-alone group (OR, 1.12 [CI, 0.78 to 1.61] for combined disease management vs. pharmacotherapy alone). Limitation: The effect of pharmacotherapy management cannot be separated from the provision of free pharmacotherapy, and cessation was validated in only 58% of self-reported quitters. Conclusion: Smokers are willing to make repeated pharmacotherapy- assisted quit attempts, leading to progressively greater smoking abstinence. Although point-prevalence abstinence did not differ at 24 months, analyses that incorporated assessments across the full 24 months of treatment suggest that higher-intensity disease management is associated with increased abstinence.